Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Keymed Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Drug: Placebo; Drug: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT04893941

CM310AD001

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.

Full description

The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
• Inadequate response to topical medications.

Exclusion criteria

• Not enough washing-out period for previous therapy.
• Concurrent disease/status which may potentially affect the efficacy/safety judgement.
• Organ dysfunction.
• Pregnancy.
• Other.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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39 participants in 5 patient groups, including a placebo group

CM310 75mg arm

Experimental group

Description:

75mg for 3 doses, every 2 weeks, SC

Treatment:

Drug: CM310

CM310 150mg arm

Experimental group

Description:

150mg for 3 doses, every 2 weeks, SC

Treatment:

Drug: CM310

CM310 300mg arm

Experimental group

Description:

300mg for 3 doses, every 2 weeks, SC

Treatment:

Drug: CM310

CM310 600(1st)+300mg(2nd,3rd) arm

Experimental group

Description:

600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC

Treatment:

Drug: CM310

placebo arm

Placebo Comparator group

Description:

placebo for 3 doses, every 2 weeks, SC

Treatment:

Drug: Placebo